CN101879227A - Chinese medicinal composition for treating protrusion of lumbar intervertebral disci and preparation method thereof - Google Patents
Chinese medicinal composition for treating protrusion of lumbar intervertebral disci and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a Chinese medicinal composition for treating protrusion of the lumbar intervertebral disci, which is characterized in that: the Chinese medicinal composition is prepared from the following raw material medicaments in part by weight: 11 to 13 parts of prepared common monkshood mother root, 9 to 11 parts of ephedra, 15 to 25 parts of astragalus, 15 to 25 parts of white paeony root, 4 to 8 parts of liquorice root, 10 to 20 parts of suberect spatholobus stem, 10 to 20 parts of clematis root and 8 to 12 parts of cassia twig. The Chinese medicinal composition for treating the protrusion of the lumbar intervertebral disci has the advantages of obvious curative effect, no obvious toxic or side effect, no contraindication and the like.
Description
Technical field
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of Chinese medicine composition for the treatment of prolapse of lumbar intervertebral disc and preparation method thereof.
Background technology:
Prolapse of lumbar intervertebral disc is commonly encountered diseases, a frequently-occurring disease clinically, and according to the interrelated data statistics, sickness rate is 1 ‰ in the population of China, and developed countries is 1.5 ‰, and the primary disease Therapeutic Method is a lot, but concludes, nothing more than operation and non-operative treatment two big classes.Foreign medical science is explored the history in existing more than 100 year to the intuitive of primary disease, Miter in 1934 and Barr cooperation first report the operative treatment of 19 routine prolapse of lumbar intervertebral disc, thereby started new era of lumbar disc surgery, medical circle is studied the treatment of primary disease both at home and abroad at present, two kinds of viewpoints are arranged substantially, the one, actively advocate operative treatment, clinical symptoms appears in all patients, and diagnose clear and definite person through physical examination, advocate operative treatment, but domestic operative treatment to prolapse of lumbar intervertebral disc there is not the scope that breaks through foreign is performed the operation at present.The 2nd, advocate that expectant treatment is main, do not get rid of operation, take traditional method, Chinese and western drugs, pelvic traction, the Comprehensive Treatment of the traditional Chinese medical science such as epidural sealing, the combination of Chinese and Western medicine, most patients can both obtain satisfied curative effect, so the latter is accepted by patient easily.Because operation is wound after all, and all kinds of corrupt practices creep in for operative treatment, deformity such as the lumbosacral region nerve, reasons such as congenital different in nature vertebra, often physical examination and clinical sign are inconsistent, so success rate of operation is paced up and down for a long time about 80%,, cause medical tangle person of common occurrence owing to blindly pursue operation.
At present, Chinese medicine still belongs to blank in treatment prolapse of lumbar intervertebral disc field, the present invention is summing up on Comprehensive Treatment success and the failure experience basis, following " Medical Treasures of the Golden Chamber " carries: " suffering from arthritis unable to flex and stretch the extremities; pain; the Aconiti Decoction master it " the theory enlightenment, through a large amount of experimental studies, find a kind of Chinese medicine composition of effective treatment prolapse of lumbar intervertebral disc.
Summary of the invention:
The Chinese medicine composition that the purpose of this invention is to provide a kind of effective treatment prolapse of lumbar intervertebral disc.
Another object of the present invention provides the preparation method of the Chinese medicine composition of this treatment prolapse of lumbar intervertebral disc.
The objective of the invention is to be achieved through the following technical solutions:
The inventor gropes to obtain a kind of Chinese medicine composition of effective treatment prolapse of lumbar intervertebral disc by a large amount of experiments, said composition is prepared by following bulk drugs: Radix Aconiti Preparata 11-13 weight portion, Herba Ephedrae 9-11 weight portion, Radix Astragali 15-25 weight portion, Radix Paeoniae Alba 15-25 weight portion, Radix Glycyrrhizae 4-8 weight portion, Caulis Spatholobi 10-20 weight portion, Radix Clematidis 10-20 weight portion, Ramulus Cinnamomi 8-12 weight portion.
Above-mentioned composition is preferably prepared by following bulk drugs: Radix Aconiti Preparata 12 weight portions, Herba Ephedrae 10 weight portions, the Radix Astragali 20 weight portions, the Radix Paeoniae Alba 20 weight portions, Radix Glycyrrhizae 6 weight portions, Caulis Spatholobi 15 weight portions, Radix Clematidis 15 weight portions, Ramulus Cinnamomi 10 weight portions.
Above-mentioned composition can adopt the conventional method of Chinese medicine preparation to be prepared into any conventional oral formulations.As the adjuvant that adds the pharmacy permission prepares granule, capsule, tablet or pill.
Radix Aconiti Preparata in the side (Radix aconiti praeparata) is the processed product of Radix Aconiti, and is hot, bitter, hot; Poisonous.Dispelling cold and dehumidification, alleviate pain, Herba Ephedrae (Herba ephedrae), Ramulus Cinnamomi (Ramulus cinnamomi) warming the meridian, a surname's numbness, collateral dredging, the Radix Paeoniae Alba (Radix paeoniae alba) yin fluid astringing, harmonizing yingfen and weifen, Radix Glycyrrhizae (Radix et rhizoma glycyrrhizae) emergency, Shujin, detoxifcation, the Radix Astragali (Radix astragali) benefiting QI for strengthening the superficies, help Aconitum carmichjaelii Debx., the Herba Ephedrae warming the meridian, diaphoresis, pain relieving, the Radix Astragali, Radix Paeoniae can prevent Herba Ephedrae again, Ramulus Cinnamomi is crossed the fraud of antiperspirant, Radix Clematidis (Radix et rhizome clematidis) helps the expelling wind and removing dampness removing obstruction in the collateral to relieve pain, Caulis Spatholobi (Caulis spatholobi) is strengthened the function of promoting blood circulation to remove obstruction in the collateral, all medicine compatibilities, can make the evil slight perspiration of cold-damp and separate, pathogenic factor goes and healthy energy is not hindered.
The preparation method of active component of the present invention can be according to following step: all medical materials add the water that medical material gross weight 5-10 doubly measures, soak after 1-2 hour, decoct 2-4 time, each 1-2 hour, merging filtrate, relative density 1.15-1.25 when being evaporated to 50～60 ℃ adds ethanol and stirs evenly, and makes medicinal liquid contain the alcohol amount and reaches 50-70%, leave standstill, filter, decompression filtrate recycling ethanol and relative density 1.20-1.30 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.
Above-mentioned preparation method preferred steps is: all medical materials are added 8 times of amounts of water, soak after 1 hour, decoct each 2 hours 2 times, merging filtrate, relative density 1.20 when being evaporated to 50～60 ℃, take advantage of hotly slightly to add ethanol and stir evenly, and make medicinal liquid contain the alcohol amount and reach 60%, leave standstill, filter, decompression filtrate recycling ethanol and relative density 1.25 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.
Beneficial effect of the present invention: Chinese medicine composition of the present invention is the expelling wind and cold that has that obtains under Chinese medical theory instructs, promoting the flow of QI in the collateral by warming the meridian, the compositions of the effect of diffusing impediment and relieving pain, clinical and experimentation shows that present composition treatment prolapse of lumbar intervertebral disc is evident in efficacy, and pharmaceutical composition of the present invention also has advantages such as side effect is little, no contraindication.Tradition adopts in the decoct of Radix Aconiti, and in order to reduce the toxic and side effects of Aconitum carmichjaelii Debx., in the decoction process of decoction, Radix Aconiti Preparata often need be decocted first 20～30 minutes, and safety control is relatively poor, and decocts loaded down with trivial detailsly, takes inconvenience.In addition, the preparation method of the present composition adopts modern production technology, active component extracts fully, toxicity reduces, and has the clinical convenience of taking safely, portably use, and toxic and side effects is little, non-invasive, advantages such as no contraindication have been filled up the blank of Chinese medicine at the treatment prolapse of lumbar intervertebral disc, have the wide development prospect.
(1) Study on Preparation of present composition active component
1, with the preferred decocting process condition of orthogonal experiment
1) Chinese crude drug adopts decocting process, and decocting time and number of times are to influence the fried principal element of effective ingredient, and the routine operation with reference to Chinese crude drug decoction at present carries out L by four factors, three levels
9(3
4) orthogonal test.
| ??A | Amount of water (doubly) | ??5 | ??8 | ??10 |
| ??B | Soak time (h) | ??0 | ??1 | ??2 |
| ??C | Decocting time (h) | ??1 | ??1.5 | ??2 |
| ??D | Decoct number of times (inferior) | ??2 | ??3 | ??4 |
With solids yield mean-max under each factor varying level is best collocation, take all factors into consideration again save time, saving of labor, energy-conservation and reference statistical processing conclusion, find out the optimised process of decoction.
2) operational approach: get 10 prescription medical material amounts, under the operation repetitive condition, press L respectively
9(3
4) nine experimental conditions arranging of orthogonal table decoct, filtrate is surveyed dried cream yield (%), and every duplicate samples is all done three times, and concrete outcome sees Table 1.
The L of table 1 decocting process
9(3
4) orthogonal table factor level table
As can be seen from Table 1, secondly C factor affecting maximum is D, A, B.As seen from table, the second or the 3rd level of getting A is better, and second level of getting B is better, and the 3rd level of getting C is better, and the 3rd level of getting D is better, promptly soaks 1 hour, adds water 8 or 10 times, decocts 2 hours, decocts 4 times.Empirical tests is 10.60% and 10.62% by the dried cream yield of this technology, but this technology shows time-consuming power consumption slightly, soaked 1 hour and adopt, add 8 times of amounts of water, decoct each 2 hours 2 times, dried cream yield is 9.90%, both only differ 0.70%, so can preferentially adopt in the actual production: soaked 1 hour, and added 8 times of amounts of water, decoct each 2 hours 2 times.
4) purification of decoction liquor
By this process solids thing yield is 9.90%, and it is bigger than normal directly to make finished product taking dose every day, and clarity is bad, so need spissated decoction liquor is carried out necessary purification process.
An amount of ethanol of adding can be removed compositions such as starch, natural gum, protein and polysaccharide wherein in spissated decocting liquid, the determining alcohol difference, and the amount of removing impurity has notable difference.According to production experience, relative density about 1.20 was taken advantage of the hot slightly ethanol that adds and is carried out the precipitate with ethanol operation for well when the concentration of clear paste was with 50～60 ℃ before the precipitate with ethanol.Medicinal liquid is too rare, and consumption alcohol amount is bigger, and cost increases, and insoluble matter is suspended in the pure liquid, influences filter operation; Medicinal liquid is too dense, and precipitate forms comparatively fast, measures also manyly, and effective ingredient easily wraps up, and forms precipitation simultaneously, and liquor strength is feeding-up in addition, easily causes the adhesion loss, so thick paste is fixed tentatively relative density about 1.20 when being 50～60 ℃ before this product precipitate with ethanol.As can be seen from Table 2, alcohol precipitation concentration reaches reuse water dissolution behind 50% o'clock extract dry, and clarity is better, but precipitate with ethanol operation difficulty slightly, precipitate is suspended in the solution, so this product alcohol precipitation concentration is preferably 60%.
Table 2 precipitate with ethanol situation analysis table
So this product production technology is preferably: all medical materials add 8 times of amounts of water, soak after 1 hour, decoct 2 times, each 2 hours, merging filtrate, relative density about 1.20 when being evaporated to 50～60 ℃, take advantage of and hotly slightly add ethanol and stir evenly, make medicinal liquid contain the alcohol amount and reach 60%, leave standstill, filter decompression filtrate recycling ethanol and relative density about 1.25 when continuing to be concentrated into 50～60 ℃.
The specific embodiment
Below further set forth the beneficial effect of medicine of the present invention by testing example, these are tested examples and comprise that the pharmacodynamics test of medicine of the present invention (to call black numb granule in the following text) and clinical observation on the therapeutic effect test.
Test example 1 medicine anti-inflammatory and analgesic effect of the present invention:
1 experiment material
11 are subjected to the reagent thing: black numb granule (provided by the Drug Manufacturing Room of Jiangsu TCM Hospital, prepare according to the method for embodiment 1), face with preceding and be made into desired concn with distilled water; Dimethylbenzene (Shanghai chemical reagent purchasing and supply station is sold); Aspirin (sell in medication purchasing supply station, Nanjing); Carrageenin (the Shenyang drug abuse test is sold); Dexamethasone (production of Jiangyin pharmaceutical factory), Rotundine Tablets (Donglan, Guangxi pharmaceutical factory) is produced, Aconiti Decoction group (Herba Ephedrae 9g, Radix Paeoniae 9g, Radix Astragali 9g, Radix Glycyrrhizae Preparata 9g, Radix Aconiti 6 grams; Radix Aconiti decocted 1 hour for 400 milliliters with Mel earlier, filtered, and filtrate device is in addition deposited.Medicinal residues and all the other four Chinese medicine materials with frying in shallow oil twice, add 400 milliliters in water for the first time again, decoct 2 hours, add 300 milliliters in water for the second time, decoct 1 hour, merge three times filtrate, are concentrated into about 140 milliliters and prepare Aconiti Decoction.)
12 animal subject ICR mices, body weight 20 ± 0.6g, male and female half and half are provided by Nanjing Medical University's Experimental Animal Center;
The SD rat is provided by Nanjing medical courses in general Imperial College animal center.
2 experimental techniques and result
The experiment of 21 antiinflammatories
21.1 mice dimethylbenzene auricle edema method is got 60 of ICR mices, is divided into 6 groups at random, 10 every group, male and female half and half normal control group gives the equivalent normal saline, aspirin group 02gkg
-1, black numb granule I group 18gkg
-1, black numb granule II group 36gkg
-1, black numb granule III group 72gkg
-1, Aconiti Decoction group 7gkg
-1Each treated animal gastric infusion, administration capacity 20ml.kg
-1Mus is heavy, every day 1 time, continuous 5 days.30min after the last administration is applied to the wide two sides of mouse right ear with crucian carp 30 μ l dimethylbenzene and causes inflammation, and left ear is contrast, dislocation of cervical vertebra is put to death after causing scorching 1h, lays auricle with the 8mm card punch in the same area of left and right sides ear, weighs, the difference of left and right sides auricle weight is the swelling degree, calculates swelling and suppresses percentage rate.Experimental result (seeing Table 3) shows, black numb granule 36gkg
-1, 72gkg
-1, xylol induced mice auricle edema all has inhibitory action, wherein 72gkg behind the oral administration
-1The inhibitory action that highly significant is arranged.
The black numb granule xylol of table 3 causes the influence of mice auricle swelling
| Grouping | Drug dose (gkg -1) | Swelling degree (mg) | Swelling suppresses percentage rate (%) |
| The normal saline group | ??15±2.3 | ||
| The numb granule small dose group of crow | ?18 | ??12.1±6.7 * | ??20.91 |
| Dosage group in the numb granule of crow | ?36 | ??11.7±4.8 △ | ??23.53 |
| The heavy dose of group of the numb granule of crow | ?72 | ??8.1±4.7 ▲ | ??17.06 |
| The Aconiti Decoction group | ?7 | ??12.4±4.3 △ | ??21.05. |
| The aspirin group | ?0.2 | ??6.5±3.9 ▲ | ??57.52 |
Annotate with the normal saline group and compare; * P＞0.05. △ P＜0.05, ▲ P＜0.01
2.1.2 rat carrageenan pedal swelling method is got 60 of SD rats, body weight 160g soil 8g. is divided into 6 groups at random, 10 every group, and male and female half and half.The normal control group gives the equivalent normal saline. Dexamethasone group 5mgkg
-1. black numb granule I group 10gkg
-1, black numb granule II group 20gkg
-1, black numb granule III group 40gkg
-1, Aconiti Decoction group 7gkg
-1, each treated animal gastric infusion. and dosage 10mlkg
-1Mus is heavy. and every day 1 time, continuous irrigation stomach 7 days after last administration half an hour, causes inflammation at rat right hind leg foot plantar subcutaneous injection 1 carrageenin suspension 0.1ml respectively.Subsequently, surveyed 1 sufficient sole of the foot volume every 1 hour, continuous 6 times, the record result. and be calculated as follows the swelling rate respectively.Swelling rate (%)=((cause the scorching front foot sole of the foot volume of the scorching front foot sole of the foot volume of scorching metapedes sole of the foot volume-cause/cause] * 100%.Experimental result (seeing Table 2) shows behind the black numb granule oral administration due to the on Carrageenan that too the Mus pedal swelling has the swelling of obviously going down to respect fruit, wherein 10gkg
-1, 20gkg
-1Dosage detumescence effect can be kept 3h, 40gkg
-1Dosage detumescence effect can be kept 6h, shows that black numb granule has tangible antiinflammatory action.
2.2 analgesic experiment
22.1 the hot pulling manipulation of mice: mice is put on the hot plate (55 ℃ ± 0.5 ℃) to the metapedes required time occurring licking, as the pain threshold of this Mus.Get pain and castrate 60 of qualified (5-30 second) female mices. be divided into 6 groups at random.If normal control group, rotundine group and black numb granule small dose group, middle dosage group and heavy dose of group.Each group of test gives equal-volume warm water or medicinal liquid, administration capacity 20mlkg respectively
-1Dosage is respectively rotundine 80mgkg
-1, the low dose of 18gkg of black numb granule
-1, middle dosage 36gkg
-1, heavy dose of 72gkg
-1, Aconiti Decoction group 7gkg
-1, every day 1 time, continuous 7 days, behind last administration 15min, 30min, 60min, measure each group pain fault value.
2.2.2 mouse writhing method
Turning round body analgesia method test mice sex is regardless of.Laboratory animal number and grouping, each organizes dosage, the same hot plate method of medication sky number average.Behind last administration 30min. the freshly prepared 0.5% acetum 0.2ml of lumbar injection, the record mice writhing response time occurs and interior each Mus of 10min is turned round body number of times (with the abdominal part indent, stretch hind leg, buttocks is raised and is standard), calculates the writhing response suppression ratio.The writhing response suppression ratio is no analgesic activity (0) less than 25%; The writhing response suppression ratio is weak analgesic activity (△) in 25～40% scopes; The writhing response suppression ratio is a moderate analgesic activity (▲) in 40%～55% scope; The writhing response suppression ratio is strong analgesic activity (★) greater than 55%.The writhing response suppression ratio=[(matched group is on average turned round body number of times-administration group and on average turned round the body number of times)/matched group is on average turned round body number of times * 100%.
The black numb granule on Carrageenan of table 4 causes the influence of rat paw edema
Table 5 hot-plate analgesic test result
Table 6 writhing method analgesic test result
| Grouping | Dosage (g.kg -1) | ??n | Turn round body time of occurrence (min) | Turn round body number of times (10min) | Analgesia rate (%) |
| The normal control group | ??0 | ??10 | ??4.85±0.77 | ??11.1±1.79 | |
| The rotundine group | ??0.08 | ??10 | ??7.86±1.61 ★ | ??1.7±0.95 ★ | ?84.70 ★ |
| The numb granule small dose group of crow | ??18 | ??10 | ??5.01±0.56 | ??10.1±2.42 | ?9.09 |
| Dosage group in the numb granule of crow | ??36 | ??10 | ??5.86±0.57 ★ | ??9.7±2.63 | ?12.69 |
| Grouping | Dosage (g.kg -1) | ??n | Turn round body time of occurrence (min) | Turn round body number of times (10min) | Analgesia rate (%) |
| The heavy dose of group of the numb granule of crow | ??72 | ??10 | ??6.47±0.68 ★ | ??7.0±2.16 ★ | ?36.99 △ |
| The Aconiti Decoction group | ??7 | ??10 | ??5.62±0.51 ★ | ??9.9±2.45 | ?9.87 |
Annotate: compare with matched group: * P＜0.01, ★ is for having strong analgesic activity; △ is for having weak analgesic activity; ▲ be the moderate analgesic activity
Experimental result (seeing Table 5,6) shows that black numb granule all has certain analgesic activity in two kinds of analgesic test.Each group of black numb granule is at medication 15min in the hot plate analgesic test, 30min, behind the 60min, its pain fault time has certain prolongation respectively, compare with matched group, crow numb small dose group (P＜0.05) behind medication 60min, in the dosage group in medication after 15 minutes (P＜0.05), medication 30min, behind the 60min (P＜0.01). heavy dose of group then is (P＜0.01) 3 times, illustrate that black numb granule effect is rapid-action, though and can keep 1h above in turning round the body analgesic test 3 dosage groups of black numb granule analgesia rate surpass 55%, but turn round body time number average for 3 groups the minimizing of deciding degree is arranged, heavy dose of group compares with matched group, its difference has significance (P＜0.01) experimental result and points out black numb granule that certain analgesic activity is arranged, and certain dose-effect relationship is arranged, and its analgesic activity is still effective behind medication 60min.
Experimental studies results shows that xylol induced mice auricle edema all has inhibitory action behind the black numb granule oral administration, wherein heavy dose of group (72gkg
-1) inhibitory action of highly significant arranged; Rat paw edema has significantly go down swelling effect, wherein 10gkg due to the on Carrageenan
-1, 20gkg
-1Dosage group detumescence effect can be kept 3h, 40gkg
-1Dosage detumescence effect can be kept 6h.The numb granule of crow can obviously improve the mice hot plate method threshold of pain, suppresses mice acetic acid twisting response rate, and two kinds of analgesic test show that black numb granule has certain analgesic activity, and certain dose-effect relationship is arranged, and its analgesic activity is still effective behind medication 60min.This medical instrument of experiment prompting has anti-inflammatory and analgesic effect preferably.The crow clinical clinical treatment prolapse of lumbar intervertebral disc of numb granule (cold-damp syndrome and blood stasis symptom), its pain relieving is quick, and is evident in efficacy, and no less than nonsteroidal spasmolysis and analgesia Western medicine, and significantly be better than contained Aconiti Decoction in the golden deficient general plan.
2.2.3 the research of medicine acute toxicological experiment of the present invention
Crow numb granule (method according to embodiment 1 prepares) is peroral administration mtd test result show, no overt toxicity reacted after 20 mices were pressed 480g/kg dosage filling stomach, did not also have dead in 1 week.This dosage is 800 times of clinical adult oral dose on the 1st, promptly 72.7 of dose,equivalent times, shows that black numb granule takes safety.In the clinical observation also none example toxic and side effects appears.
The peroral administration mtd test result of Aconiti Decoction: 20 mices are irritated behind the stomach by 375g/kg dosage has 3 death in 1 week.This dosage is 536 times of clinical adult oral dose on the 1st, promptly 48.7 of dose,equivalent times.Show that by acute toxicity test the numb particulate toxicity of crow is significantly less than Aconiti Decoction.
The clinical observation of test example 2 Drug therapy prolapse of lumbar intervertebral disc of the present invention
1, physical data:
Patient's 35 examples, male's 20 examples, women's 15 examples, M-F 4: 3; In age 20-60 year, the mean age is 48 years old; Disease burst person 13 examples, chronic author's 22 examples; The course of disease 6 months is with interior person's 22 examples, person's 13 examples more than 6 months; Prolapse of lumbar intervertebral disc recurrence after operation person 2 examples; The disease type belongs to cold-dampness type 24 examples, blood stasis type 11 examples; Waist CT shows extrusion position in L3,41 examples, L4,5 16 examples, 8 examples between L5, S1, L3,4 and outstanding simultaneously 2 examples of L4,5, outstanding simultaneously 8 examples of L4,5 and, L5, S1; CT shows intercalated disc extrusion position side 15 examples of taking back, the side that takes over 11 examples, central type 9 examples, outstanding companion's spinal canal stenosis person 2 examples.
2, diagnostic criteria
Prolapse of lumbar intervertebral disc diagnostic criteria (1) has the waist trauma history, chronic strain or cold-damp person, and most of patient has the chronic back pain history at premorbid.(2) lumbago is to buttocks and lower limb radiation, and pain increased the weight of when abdominal pressure increased.(3) scoliosis, lumbar vertebra physiology orphan degree disappears or is straight, the other tenderness of diseased region vertebra, and to lower limb radiation, waist limitation of activity.(4) lower limb are got involved, and innervation district skin is felt irritated or blunt, and amyotrophy can appear in course of disease elder, and straight-leg raising test and reinforcement test are positive, and patellar tendon, Achilles tendon reflex weaken or disappear, and the big toe back of the body is stretched, sole of the foot musculus flexor muscular strength weakens.(5) X-ray film inspection, but spinal column lateral bending. lumbar vertebra physiology prolapse disappears, and the pathological interspinal crack can narrow down, neighboring edge vertebral body hyperosteogeny; CT picks up the position and the degree that can show that intervertebral is outstanding of looking into. and the visible diseased region of nuclear magnetic resonance, NMR has the extrusion phenomenon.
3, Therapeutic Method
The numb granule of oral crow (method according to embodiment 1 prepares) 3 times on the 1st, each 12g, boiled water is taken after mixing it with water, and observing for 4 weeks is a course of treatment.Make efficacy evaluation.Be not taken by pregnant women.During the treatment, the patient to be to lie up, and stops waist and bears a heavy burden local hot compress. and behind the sx, actively make waist exercise and two lower limb and replace straight lower limb and be raised to maximum tolerated dose.
4, efficacy assessment standard
Clinical recovery: lumbago and skelalgia disappears, and straight lower limb is raised 〉=80 degree, can recover former work;
Produce effects: lumbago and skelalgia obviously alleviates, but still has symptom after overcast and rainy and tired, and straight lower limb is raised the 60-70 degree, can participate in light work;
Take a turn for the better: lumbago and skelalgia alleviates, and the waist movable function improves, and straight lower limb improves before raising treatment;
Invalid: treatment back symptom, sign do not have improvement.
5, therapeutic outcome:
This organizes 35 examples, and through 4 weeks following the tracks of treatment, the result: clinical recovery 14 examples account for 40%; Produce effects 10 examples account for 28.75%; Effective 9 examples. account for 25.71%; Invalid 2 examples account for 5.72%.Total effective rate is 94.28%.
CT contrast: after the treatment of 4 weeks, carry out the CT contrast. wherein, 14 person's of falling clinical recovery intervertebral disk hernia scopes all have dwindling in various degree, and from 1-15mm, all the other 21 routine CT see that intervertebral disc does not have obviously and dwindle.
Follow up a case by regular visits to situation: treatment is followed up a case by regular visits to later six months, and 14 routine cured persons do not have recurrence; 10 routine produce effects person is asymptomatic increases the weight of; The .5 example sx treatment of transferring from one hospital to another among the 9 routine responders, the capable operative treatment of 2 routine nonresponders.
Further set forth the preparation method of medicine of the present invention by the following examples
The preparation of embodiment 1 medicinal granule of the present invention
Prescription: Radix Aconiti Preparata 120g Herba Ephedrae 100g Radix Astragali 200g Radix Paeoniae Alba 200g
Radix Glycyrrhizae 60g Caulis Spatholobi 150g Radix Clematidis 150g Ramulus Cinnamomi 100g
The water that each raw medicinal material is added 8 times of amounts of medical material gross weight, soak after 1 hour, decoct each 2 hours 2 times, merging filtrate, relative density 1.20 when being evaporated to 50～60 ℃, take advantage of hotly slightly to add ethanol and stir evenly, and make medicinal liquid contain the alcohol amount and reach 60%, left standstill 24 hours, filter, decompression filtrate recycling ethanol and relative density 1.25 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.Press active component: Icing Sugar: the part by weight of dextrin (1: 1: 2.5) is granulated, and 80 ℃ of dryings are adorned aluminium foil bag behind granulate and the mixing, promptly get the granule for preparing.An oral 12g, 3 times on the one.
The preparation of embodiment 2 medicine capsules of the present invention
Prescription: Radix Aconiti Preparata 110g Herba Ephedrae 90g Radix Astragali 150g Radix Paeoniae Alba 150g
Radix Glycyrrhizae 40g Caulis Spatholobi 100g Radix Clematidis 100g Ramulus Cinnamomi 120g
The water that each raw medicinal material is added 5 times of amounts of medical material gross weight, soak after 1 hour, decoct each 2 hours 3 times, merging filtrate, relative density 1.25 when being evaporated to 50～60 ℃, take advantage of hotly slightly to add ethanol and stir evenly, and make medicinal liquid contain the alcohol amount and reach 50%, left standstill 24 hours, filter, decompression filtrate recycling ethanol and relative density 1.25 when continuing to concentrate 50～60 ℃ make the active component of medicine of the present invention.The adjuvant of usual pharmaceutical regulations such as this active component adding dextrin is prepared capsule.
The preparation of embodiment 3 medicinal tablets of the present invention
Prescription: Radix Aconiti Preparata 130g Herba Ephedrae 110g Radix Astragali 250g Radix Paeoniae Alba 250g
Radix Glycyrrhizae 80g Caulis Spatholobi 200g Radix Clematidis 200g Ramulus Cinnamomi 80g
The water that each raw medicinal material is added 10 times of amounts of medical material gross weight, soak after 2 hours, decoct each 1 hour 4 times, merging filtrate, relative density 1.15 when being evaporated to 50～60 ℃, take advantage of hotly slightly to add ethanol and stir evenly, and make medicinal liquid contain the alcohol amount and reach 70%, left standstill 24 hours, filter, decompression filtrate recycling ethanol and relative density 1.20 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.Adjuvant compressed tablets with usual pharmaceutical regulations such as this active component adding starch.
The preparation of embodiment 4 bolus of drug of the present invention
Prescription: Radix Aconiti Preparata 120g Herba Ephedrae 110g Radix Astragali 180g Radix Paeoniae Alba 220g
Radix Glycyrrhizae 50g Caulis Spatholobi 170g Radix Clematidis 180g Ramulus Cinnamomi 90g
The water that each raw medicinal material is added 8 times of amounts of medical material gross weight, soak after 1 hour, decoct each 2 hours 2 times, merging filtrate, relative density 1.20 when being evaporated to 50～60 ℃, take advantage of hotly slightly to add ethanol and stir evenly, and make medicinal liquid contain the alcohol amount and reach 60%, left standstill 24 hours, filter, decompression filtrate recycling ethanol and relative density 1.30 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.The binding agent that this active component is added the usual pharmaceutical regulation makes pill.
Claims (5)
1. Chinese medicine composition for the treatment of prolapse of lumbar intervertebral disc, it is characterized in that said composition mainly is to be made by following bulk drugs: Radix Aconiti Preparata 11-13 weight portion, Herba Ephedrae 9-11 weight portion, Radix Astragali 15-25 weight portion, Radix Paeoniae Alba 15-25 weight portion, Radix Glycyrrhizae 4-8 weight portion, Caulis Spatholobi 10-20 weight portion, Radix Clematidis 10-20 weight portion, Ramulus Cinnamomi 8-12 weight portion.
2. the Chinese medicine composition of treatment prolapse of lumbar intervertebral disc according to claim 1, it is characterized in that said composition mainly is to be made by following bulk drugs: Radix Aconiti Preparata 12 weight portions, Herba Ephedrae 10 weight portions, the Radix Astragali 20 weight portions, the Radix Paeoniae Alba 20 weight portions, Radix Glycyrrhizae 6 weight portions, Caulis Spatholobi 15 weight portions, Radix Clematidis 15 weight portions, Ramulus Cinnamomi 10 weight portions.
3. the Chinese medicine composition of treatment prolapse of lumbar intervertebral disc according to claim 1 and 2 is characterized in that the adjuvant that said composition adding pharmacy allows prepares granule, capsule, tablet or pill.
4. the preparation method of claim 1 or 2 described medicines is characterized in that it comprises the steps:
Each raw medicinal material is added the water that medical material gross weight 5-10 doubly measures, soak after 1-2 hour, decoct 2-4 time, each 1-2 hour, merging filtrate, relative density 1.15-1.25 when being evaporated to 50～60 ℃ adds ethanol and stirs evenly, and makes medicinal liquid contain the alcohol amount and reaches 50-70%, leave standstill, filter, decompression filtrate recycling ethanol and relative density 1.20-1.30 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.
5. the preparation method of medicine according to claim 4 is characterized in that it comprises the steps:
The water that each raw medicinal material is added 8 times of amounts of medical material gross weight, soak after 1 hour, decoct each 2 hours 2 times, merging filtrate, relative density 1.20 when being evaporated to 50～60 ℃, add ethanol while hot and stir evenly, and make medicinal liquid contain the alcohol amount and reach 60%, leave standstill, filter, decompression filtrate recycling ethanol and relative density 1.25 when continuing to be concentrated into 50～60 ℃ make the active component of medicine of the present invention.
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